Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2024-02-14

Brief Summary

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This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.

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Detailed Description

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This is a two-part, Phase 2, double-blind, placebo-controlled, randomized, multicentre study.

Subjects with a diagnosis of PD and dyskinesias in PD will complete a Screening Visit to assess eligibility to participate in the study.

Conditions

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Dyskinesias Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind

Study Groups

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Part 1, JM-010 component Group A

Group Type EXPERIMENTAL

Part 1, JM-010 component Group A

Intervention Type DRUG

JM-010 component Group A

Part 1, JM-010 component Group B

Group Type EXPERIMENTAL

Part 1, JM-010 component Group B

Intervention Type DRUG

JM-010 component Group B

Part 1, JM-010 component Group C

Group Type EXPERIMENTAL

Part 1, JM-010 component Group C

Intervention Type DRUG

JM-010 component Group C

Part 1, Placebo Group

Group Type PLACEBO_COMPARATOR

Part 1, Placebo Group

Intervention Type DRUG

Placebo Group

Part 2, JM-010 combination Group A

Group Type EXPERIMENTAL

Part 2, JM-010 combination Group A

Intervention Type DRUG

JM-010 combination Group A

Part 2, JM-010 combination Group B

Group Type EXPERIMENTAL

Part 2, JM-010 combination Group B

Intervention Type DRUG

JM-010 combination Group B

Part 2, JM-010 component Group C

Group Type EXPERIMENTAL

Part 2, JM-010 component Group C

Intervention Type DRUG

JM-010 component Group C

Part 2, Placebo Group

Group Type PLACEBO_COMPARATOR

Part 2, Placebo Group

Intervention Type DRUG

Placebo Group

Interventions

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Part 1, JM-010 component Group A

JM-010 component Group A

Intervention Type DRUG

Part 1, JM-010 component Group B

JM-010 component Group B

Intervention Type DRUG

Part 1, JM-010 component Group C

JM-010 component Group C

Intervention Type DRUG

Part 1, Placebo Group

Placebo Group

Intervention Type DRUG

Part 2, JM-010 combination Group A

JM-010 combination Group A

Intervention Type DRUG

Part 2, JM-010 combination Group B

JM-010 combination Group B

Intervention Type DRUG

Part 2, JM-010 component Group C

JM-010 component Group C

Intervention Type DRUG

Part 2, Placebo Group

Placebo Group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
* Is male or female, between 18 and 85 years of age at Screening Visit.
* Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
* Has experienced dyskinesia
* Has stable peak-effect dyskinesia
* Has more than one hour of "ON" time with troublesome dyskinesia

Exclusion Criteria

* Has undergone surgery for the treatment of PD
* Has a current diagnosis of Substance Use
* Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
* Has current seizure disorders requiring treatment with anticonvulsants.

Other criteria related to other medical conditions to be referred to the protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No